Jamie O’Connor

Care Quality Commission 
Citygate 
Gallowgate 
Newcastle upon Tyne 
NE1 4PA 

www.cqc.org.uk 

HM Assistant Coroner Hocking 
Leicester City and South Leicestershire Coroner 

14 January 2022 

Dear HM Coroner Hocking 

Regulation 28 Report following the inquest into the death of Jamie Francis 

We write further to the Regulation 28 report that you made following the inquest into 
. 
the sad death of 

Prevention of Future Deaths Report 

Under Section 5 of your report entitled you noted: 
1.There is no central tracking system or central database to record what each person 
has been prescribed and dispensed and by whom. This is open to abuse as the 
person requesting the drugs has potential access to multiple online pharmacies who 
have no knowledge of what each other have been prescribing thus risking contra-
indicated drugs being dispensed or over prescribing of drugs. 
2. There is no requirement to contact the GP of the person requesting drugs to let 
them know what has been prescribed. If the person requesting the drugs chose not 
to share with the GP there were no red flags which might indicate further enquiries 
should be made with that person as to why they did not want to share with the GP. 
3. There was no necessity for a face to face consultation with the person requesting 
the drugs and the prescriber before drugs were dispensed; 
4. There was a very limited questionnaire about the history of the person requesting 

not be prescribed it was very easy to go back and a 
that meant that the drugs could be dispensed; 
5. Persons requesting the drugs were able to ask specifically for which drug they 
wanted before contact with the prescriber; 
6. By virtue of where the company prescribing the drugs was registered there was 
limited regulation. 

20211208 Final Response to Regulation 28 report Jamie OConnor v1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 CQC inspection of online provider services 

As you are already aware the Care Quality Commission (CQC) is the independent 

ure health 

and social care services provide people with safe, effective, compassionate, high-quality 
ca 
and adult social care service providers in England; to monitor, inspect and rate services; 
and to take action to protect people where appropriate using its powers under Health 
and Social Care Act 2008 and associated regulations. 

CQC registers those providers who fall within the scope of regulation as defined by the 
Health and Social Care Act and associated Regulations. This means in order to be 
regulated by the CQC they must be providing defined activities in a manner which brings 
them in to regulation. 

CQC regulates providers of online primary care services based in England where they 
are delivering a regulated activity by an online means to patients in England. This 
includes providers prescribing medicines in response to online forms, where those 
healthcare professionals employed to provide the service fall within the list of healthcare 
professionals defined in the scope of registration. In addition, all UK healthcare 
professionals are subject to their respective codes of professional conduct and these are 
enforced by, for example, the GPhC for pharmacists or the General Medical Council 
(GMC) for doctors. 

gulation we inspect against the 

regulations using an inspection framework. All providers must comply with the 
regulations as set out in The Health and Social Care Act 2008 (Regulated Activities) 
Regulations 2014 (RAR 2014). The regulations that would be most relevant to any 
reviews around online providers, would include, but not be limited to, the following: 

Regulation 9 (Person-Centred Care); 
Regulation 11 (Need for Consent); 
Regulation 12 (Safe Care and Treatment including the safe use of medicines); 
Regulation 13 (Safeguarding service users from abuse and improper treatment); 
And 
Regulation 17 (Good Governance) 

As part of our inspection of online providers CQC routinely checks the management of 
medicines, prescriptions, consent and sharing i 

prescriptions in this way can be restricted where patients have not provided consent to 
share information and/or where a patient has used alternative identification. 

CQC has published guidance for providers1. The guidance describes the expectations of 

service. We also expect that should the patient decline to consent for the sharing 

ed of prescribed medications from their 

1 How CQC monitors, inspects and regulates ONLINE PRIMARY CARE, April 2019 
The State of Care in Independent Online Primary Care Services, May 2019 

20211208 Final Response to Regulation 28 report Jamie OConnor v1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 of such information to take place, the prescriber should consider whether it is still safe to 
continue and accept the full responsibility for their actions and act in line with GMC 
prescribing guidance. 

nce with the regulations will be assessed at inspection. 

As part of a CQC comprehensive inspection the online provider will be inspected against 
five key questions, whether a service is safe, effective, caring, responsive and well led. 
Each of the five key questions are broken down into a further set of questions, the key 
lines of enquiry (KLOEs). When CQC inspects, these are used to help CQC decide what 
the inspection needs to focus on. For example, the inspection team will look at the 
management of medicines and prescriptions, consent, identity checks and sharing 
information wi 
whether a service is safe, effective, caring, responsive or well led, CQC will consider 
how governance systems, processes and practices keep people safe, how these are 
monitored and improved and whether staff receive effective training in safety systems, 
processes and practices. 

Where there are concerns a provider is operating carrying on a regulated activity falling 
within the scope of CQC registration without registration the CQC powers to investigate. 
Specifically, under section 10 of the Health and Social Care Act 2008 (section 10 HSCA 
2008) it is an offence for persons to carry on regulated activities without being registered 
with the CQC to do so. Where it is brought to our attention that a provider may be 
offering a service that requires registration we do investigate and take such action as is 
necessary to bring them into regulation. CQC does investigate and has prosecuted the 
online provision of regulated activities without registration. 

as set out in your Regulation 28 report. 

Through our regulation of independent online primary medical services, CQC has 
identified gaps in the regulatory framework for independent online providers. We 
continue to have concerns about safety gaps, which generally align to those you have 
identified. We do however recognise there are benefits in the provision of online 
services, and for consultations and prescribing without the need for a face to face 
consultation where there are appropriate safeguards in place. These include history 
taking, engagement with the registered GP, and monitoring, as well as a risk assessing 
those medicines that are prescribed by a service. Our specific concerns are in the 
following areas: 

over prescribing of opioids and other medicines online, including those with the potential 
for misuse; 
prescribing online without verified knowled 
patient records, and 
GP; 
the type and quantities of medicines that can be prescribed by independent providers 
online; 
the lack of measures and checks in place when medicines are dispensed in England, 
following a prescription from outside England or non-NHS prescriptions; and 
generally, there is limited jurisdictional ability for UK regulators to take action in 
response to harmful prescribing by providers or registered persons based outside the 
UK. 

20211208 Final Response to Regulation 28 report Jamie OConnor v1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 We are also aware that our regulatory partners, including MHRA and the GPhC, share 
our concerns about the lack of regulatory oversight in this area. 

In the last few years, CQC has extensively engaged with members of a UK-wide cross-
regulatory forum to improve oversight of online primary care providers. We have been 
working with our regulatory partners to ensure that the gaps in regulation are mitigated 
to the best of our abilities and within the limits of our, and their, regulatory powers. 

We recognise the regulatory framework in this area needs to be updated to address 
emerging risks and to ensure independent online prescribers adhere to safe practice. 

Since January 2021 CQC has been in formal discussion with, and submitted proposals 
for legislative changes to, the Department of Health and Social Care (DHSC) to improve 

risk. 

We are keen to look at how 
as outlined above, as well as to address current and emerging threats to the health, 
safety and wellbeing of service users from online providers. This includes looking at 
what issues can be addressed through legislative change. CQC is continuing to work 
closely with our partners, other regulators (including MHRA and GPhC) and other 
government organisations to explore other opportunities for taking this work forward. 

We do hope that this response addresses your concerns. Should you require any further 
information then please do not hesitate to contact us. 

Yours sincerely 

Head of Integrated Care and GP Inspection, Midlands 
Care Quality Commission 

20211208 Final Response to Regulation 28 report Jamie OConnor v1

• 

Department 
of Health & 
Social Care 

From the Lord Kamal/
Parliamentary Under Secretary of State for Innovation {Lords) 

39 Victoria Street 
London 
SW1H0EU 
Tel: 020 7210 4850 

Our Ref: PFD 1381869 

D Hocking 
Assistant Coroner 
for the area of Leicester City and South Leicestershire 
Her Majesty's Coroner's Office 
Town Hall 
Town Hall Square 
Leicester 
LE1  9BG 

Dear Mrs Hocking, 

30 August 2022 

Thank you for your letter of 21  October 2021  about the death. of Jamie O'Connor.  I have been asked 
to reply as  Minister with responsibility for  Medicines and  am grateful for the additional  time allowed 
for me to do so. 

I was  sad  to  read  of the circumstances of Jamie O'Connor's death.  I and  my department offer our 
sincere condolences to his family and loved ones.  The circumstances described in your report are 
very concerning,  so  I am grateful to you for bringing these matters to my attention. 

I should make it clear that in  preparing this response,  Departmental officials have enquiries with the 
Medicines  and  Healthcare  products  Regulatory Agency (MHRA),  General  Pharmaceutical  Council 
(GPhC), NHS England and  NHS Improvement, as well as the Care Quality Commission. 

I am advised  that in the UK, medicines {for human use) are subject to strict legal controls under the 
Human .Medicines  Regulations 2012.  The  legislation provides  for schemes to authorise medicinal 
products and to license their manufacture and distribution. 

Medicines are classified in one of three categories: 

•  Prescription only (POM); or 
•  Pharmacy; or 
•  General Sales list products. 

POMs {including  those that are also subject to control under Misuse of Drugs Regulations),  should 
only  be  dispensed  against a  prescription  from  a  relevant  healthcare  provider -
including  private 
prescriptions - and ,can be issued electronically.  Relevant providers include doctors registered in the 
European Economic Area member state, as well as pharmacists that are independent prescribers. 

The MHRA has reviewed the supply of POMs to Mr O'Connor exchange information with the 
relevant regulators, CQC and GP,hC.  Enquiries revealed that the medicines were supplied in 
accordance with a prescription issued by an appropriate healthcare provider and consequently, no 
breach of regulatory requirements in the Human Medicines Regulations 2012 appear to have 
happened. 

 The Department is working with  other healthcare regulators  including  the General  Medical  Council 
and  their  equivalents  in  Scotland,  Wales  and  Northern  Ireland  in  the  area  of digital  healthcare 
provision.  As  a result,  a review of the UK's legislative position was undertaken and gaps identified. 
These included cases  involving inappropriate prescribing and a lack of checks with the patient's GP 
before prescribing. There were also concerns about the absence of phannacy records of medicines 
dispensed by other phannacies.  The Department and healthcare regulators are also working together 
to review prescribing by private prescri~ers in relation to controlled drugs. 

Ar:,  Expert ·working Group of the Commission of Human Medicines, which is the MHRA's independent 
scientific advisory body, examined the risk of dependence and addiction to opioids.  Dihydrocodeine 
is an opioid medicine authorised for the treatment of acute pain.  In April 2019, warnings were added 
to  the  packaging  to  highlight that  the  medicine  contains  an  opioid  and  to  warn  about  the  risk  of 
addiction.  In 2020, further warnings were added in the product infonnation, the Summary of Product 
Characteristics  for  healthcare  professionals  and  the  patient  infonnation  leaflet,  about  the  risk  of 
addiction. 

Further to this, on 23 September 2020 an article was published in the MHRA's electronic drug safety 
bulletin for healthcare professionals, Drug Safety Update1 (DSU) highlighting the risk of addiction and 
the potential for overdose which could be fatal.  A separate patient leaflet2 is linked to the DSU, which 
was  recently updated in  August 2021  following  user-testing to  ensure that patients can  access the 
messages.  This leaflet also highlights the issue of tolerance, where a  patient may consider that the 
medicine is not having the  same effect as  before,  and therefore feels  the  need  to  take  more than 
directed.  Phannacies have. been encouraged to provide a link to this patient leaflet on their websites 
to  increase awareness of these warnings.  The MHRA continues to review the safety and access to 
"the opioid medicines and will take any necessary regulatory action as laid in the  Human  Medicines 
Regulations 2012. 

In addition, the UK has a Yellow Card Scheme for collecting and monitoring infonnation on suspected 
adverse drug reactions (ADRs).  The Scheme is run  by the MHRA and relies on voluntary reporting 
of suspected  ADRs  by  health  professionals  and  patients.  There  is  also  a  legal  obligation  for 
pharmaceutical  companies to  report serious ADRs  associated with their drugs.  The purpose of the 
Scheme  is  to  provide  an  early  warning  that  the  safety  of  a  product  may  require  further 
investigation.  My officials have advised that Jamie O'Connor's case has been  added to the Yellow 
Card database. 

As  more  peoP,le  use the  internet to  research  health  issues,  there  have  been  more patients  going 
online to buy prescription medicine.  The guideline about advertising and promotion of medicines in 
the UK is  set out under the  Human Medicines Regulations 2012 (Part  14).  Advertising of medicinal 
products  has a  broad  definition  under the  Regulations  and  is  considered  to  be  anything  which  is 
designed to promote their pr_escription, supply,  sale or consumption.  These legal requirements are 
set out in the MHRA Blue Guide3

• 

Any  website  for consumers,  registered  in  the  UK or aimed  at  a  UK audience,  which  provides  a 
treatment service is required to comply with the law on advertising of medicines.  While websites may 
promote their treatment service, which may lead to the prescription and supply of a POM, they must 
not promote specific POMs to the public.  This is prohibited by Regulation 284, which guards against 
the  issue of an advertisement to  the  public likely to lead to use of a  POM.  The regulation  aims to 
protect  public  health  by  ensuring  that  appropriate  management  of a  condition  for  an  individual 

1  https://www.gov.uk/drug-safetv-update/opioids-risk-of-dependence-and-addiction 
2  https://assets.publishing.service.gov.uk/medial5f6a078ed3bf7f7238f23100/Opioid-patient-safety-
information-leaflet-v2-Aug2021.pdf 
3https://assets.p ubl ishing .service . .9ov.uk/govern ment/uploads/sy stem/up! oad s/attachm ent  datalfi le/9 5 
6846/BG  2020  Brexit  Final  version.pdf 

 consumer  is  undertaken  via  joint  consideration  between  prescriber  and  patient  in  a  professional 
consultation,  taking  into  account  a  potential  range  of  medical  factors  and  a  relevant  range  of 
therapeutic options. 

Appendix 6 of the Blue Guide4  provides guidance for treatment service providers that outlines how to 
promote  a  service  (and  professional  consultation)  without  breaking  the  law by  promoting  specific 
POMs to the public.  If a complaint is  received,  the decision on  whether a particular communication 
complies with the Regulations will be taken by the MHRA on a case-by-case basis, having regard to 
the  circumstances  of  the  particular  case.  Completed  investigations  are  published  on 
the 
Government's website5

• 

General principles for services such as online clinics or pharmacies include advising that they make 
information available on a particular condition and its management, which may include a factual and 
balanced  overview of the  range of therapeutic options.  Website homepages and  any linked social 
media content should focus on medical conditions and the service provided.  Casual browsers should 
not be presented  with  information  on  POMs.  Further  pages  about  a  condition  may set out non-
promotional information on specific medicines if presented as a fair overview of options. 

The MHRA also works  closely with other regulators to ensure that the public are protected from the 
advertising of POMs.  This work can involve  the  issuing of guidance for advertisers to uphold high 
standards, and joint enforcement or working closely on investigations and complaints.  These bodies 
include, but are not limited to - the Advertising Standards Authority, CQC, and the professional bodies 
for healthcare professionals.  The General Pharmaceutical Council (GPhC) is the professional body 
for  upholding  high  standards  from  the  pharmacy  profession,  including  thol?e  pr.ofessionals  who 
operate distance-selling  businesses.  GPhC guidance6  outlines how pharmacy websites should  be 
arranged so  as not to enable a  consumer to  choose  a POM and  its quantity before an  appropriate 
consultation with a prescriber has taken place. 

I  hope  this  response  addresses  the concerns  raised  in  your  PFD  report.  Please  do  contact  my 
department if any further clarification is required. I do hope we can learn from the sad death of Jamie 
O'Connor to prevent such tragedies in the future~ 

Yours sincerely, 

LORD KAMALL 

4https://assets. publishing.service.gov.uk/government/u ploads/svstem/uploads/attachment  data/fi le/95 
6859/Appendix  6,pdf 
5  htt9 s://www.gov.uk/government/collections/advertising-investigations-bv-m hra 
6https://www.pharmacyregulation.org/sites/default/file§/document/guidance  for  registered  pharmacie 
s  9 roviding  pharmacy  services  at  a  distance  including .on  the  internet  april  2019.pdf

10 December 2021 

Mrs Dianne Hocking 
Assistant Coroner for Leicester City and South Leicestershire 
The Coroner’s Court 
Town Hall, Town Hall Square 
Leicester  
LE1 9BG 
0116 454 1030  

Dear Mrs Hocking  

Regulation 28 Report to Prevent Future Deaths  

Thank you for your Regulation 28 Report ‘To Prevent Future Deaths’. I am responding as 
the Medical Director and Director of Education and Standards for the General Medical 
Council (GMC).  

I am grateful to you for raising the matter with us, and I am sorry to hear of the 
circumstances of Jamie Francis O'Connor’s death.    

The GMC is the regulator for the medical profession in the UK. As part of our role, we 
publish guidance for doctors setting out the principles of good practice and the professional 
standards expected of them in the course of their work. We do not, however, give clinical 
guidance or comment on clinical matters, such as the appropriateness of specific treatments. 
All doctors must be aware of and follow our guidance and we have powers to take action if 
those standards are not met.  

I appreciate that the events giving rise to this inquest date from several years ago. In late 
2019 we launched a call for evidence in relation to remote consultations and prescribing. 
This explored whether our existing guidance, which was last updated in 2013 and which 
applied at the time of Mr O’Connor’s death, had kept pace with changes in practice and the 
use of technology.  

Following this exercise, we published updated guidance for doctors on prescribing in 
February 2021. This now places a greater emphasis on following the principles of good 
practice regardless of the medium through which a consultation is taking place, face to face 
or online. 

We recognise that some models of remote prescribing can pose greater risks, including 
where there is no mechanism for doctors to have two-way dialogue or communication with 
patients. In our updated guidance we are clear that, if they cannot meet our standards 

 
 through the mode of consultation they are using, doctors should offer an alternative if 
possible, or signpost to other services. If doctors think that systems, policies or procedures 
are, or may be, placing patients at risk of harm, they must follow our guidance in ‘Raising 
and acting on concerns about patient safety’. 

For clarity below we have set out our response to each concern you raise, with references to 
our updated guidance. While the first and last concerns below are outside our remit, I hope 
our response to the remaining areas gives assurance that the GMC provides clear guidance 
for doctors that addresses these issues. 

‘There is no central tracking system or central database to record what each 
person has been prescribed and dispensed and by whom. This is open to abuse as 
the person requesting the drugs has potential access to multiple online 
pharmacies who have no knowledge of what each other have been prescribing 
thus risking contra-indicated drugs being dispensed or over prescribing of drugs.’ 

Systems for accessing and sharing information about the prescribing and dispensing of 
medicines are outside the GMC’s remit. However, we strongly agree that effective systems 
are vital to ensuring safe and effective care.  

In our prescribing guidance we say that doctors should only prescribe medicines if they have 
adequate knowledge of the patient’s health and are satisfied that the medicines serve the 
patient’s needs (paragraph 20). It is essential that doctors and other healthcare 
professionals can easily access or verify the information they need to prescribe safely, 
especially when prescribing medicines which present a risk of addiction, misuse or overuse. 

We know doctors in both remote and face-to-face settings will sometimes find themselves in 
a position where they cannot easily access or verify the information they need to prescribe 
safely. In England, we are aware that NHSX has published a ‘Delivery Plan’, which is looking 
at how all those involved in the delivery of care can access the information they need. We 
hope this will be an opportunity to remove barriers for doctors and other healthcare 
professionals when accessing and sharing relevant patient information.   

‘There is no requirement to contact the GP of the person requesting drugs to let 
them know what has been prescribed. If the person requesting the drugs chose 
not to share with the GP there were no red flags which might indicate further 
enquiries should be made with that person as to why they did not want to share 
with the GP.’ 

Our prescribing guidance is clear that doctors must only prescribe if it is safe to do so and 
we say that: 

• 

• 

It’s not safe to prescribe if doctors don’t have sufficient information about the 
patient’s health or if the mode of consultation is unsuitable to meet their needs. 
It may be unsafe if relevant information is not shared with other healthcare providers 
involved in the patient’s care – for example because the patient refuses consent 
(paragraph 27). 

 
 In relation to accessing and sharing information, our guidance (paragraphs 29-32) says that 
if: 

•  a doctor is not the patient’s regular prescriber, they should ask for the patient’s 

• 

• 

• 

consent to contact their GP or other treating doctors if they need more information 
or confirmation of the information they have before prescribing, and to share 
information with the patient’s GP when the episode of care is completed. 
the patient objects to information being shared with the doctor, or does not have a 
regular prescriber who can be contacted, the doctor must be able to justify a 
decision to prescribe without that information.  
the patient refuses to consent to the doctor sharing information with their GP, or 
does not have a GP, the doctor should explain to the patient the risks of not sharing 
this information and document this in their medical records. 
failing to share information with others could pose a risk to patient safety, the doctor 
should explain to the patient that they cannot prescribe. The doctor should also 
outline the patient’s options and signpost them to appropriate alternative services. 
Finally, the doctor should clearly document their reasons for any decisions made. 

We have also specifically strengthened our guidance in relation to controlled drugs and 
medicines liable to abuse, overuse, misuse or addiction. This includes emphasising that, if 
doctors do not have access to relevant information from the patient’s medical records, apart 
from in limited circumstances, they must not prescribe such medicines.  

‘There was no necessity for a face to face consultation with the person requesting 
the drugs and the prescriber before drugs were dispensed’ 

Our guidance says that doctors must consider the suitability of the mode of consultation 
they are using, taking account of any need for physical examination or other assessments 
(paragraph 20a). Before prescribing, doctors must be satisfied that they can make an 
adequate assessment, establish a dialogue and obtain the patient’s consent through the 
mode of consultation they are using (paragraph 24).  

We provide further guidance on circumstances in which a face-to-face consultation may be 
more appropriate than a remote consultation. This includes, but is not limited to, when the 
doctor is not the patient’s usual doctor or GP and the patient has not given the doctor 
consent to share their information with their regular prescriber. We add that this is 
particularly important if the treatment needs following up or monitoring, or if the doctor is 
prescribing medicines where additional safeguards are needed – such as those liable to 
addiction and abuse (paragraph 22). 

We also say that, where different options exist, and it is within their power, doctors should 
agree with the patient which mode of consultation is most suitable for them (paragraph 21). 

 
 
 
 
 
 
 
 
 ‘There was a very limited questionnaire about the history of the person 
requesting the drugs. If the answer was 'no' to one question which meant that 
the drugs could not be prescribed it was very easy to go back and alter it to 'yes' 
(or vice versa) if that meant that the drugs could be dispensed.’ 

‘Persons requesting the drugs were able to ask specifically for which drug they 
wanted before contact with the prescriber.’ 

Our updated prescribing guidance highlights that, when prescribing medicines, doctors must 
establish a dialogue with their patient to help them consider information about their options 
and so they can decide whether or not to have care or treatment. We say that good 
dialogue should give both the doctor and their patient the opportunity to ask questions to 
get the information they both need (paragraph 34). 

Doctors must obtain an adequate history, which includes, but is not limited to, current and 
recent use of other medicines, including non-prescription and herbal medicines, illegal drugs 
and medicines purchased online or face to face (paragraph 35). Doctors should encourage 
their patient to be open about their use of such medicines (paragraph 36). 

We specifically say that, if it is not possible to clarify or ask for more information from the 
patient in the environment they are working, doctors should consider whether it is safe to 
prescribe, and raise concerns as appropriate. We highlight that it may, for instance, be 
appropriate to raise concerns if the system in which a doctor is working involves prescribing 
remotely on the basis of a questionnaire and there is no mechanism for two-way dialogue or 
communication with patients (paragraph 38). 

‘By virtue of where the company prescribing the drugs was registered there was 
limited regulation.’ 

The GMC’s remit does not extend to organisations that provide health services. The 
Department of Health and Social Care and the Care Quality Commission may be better 
placed to comment on this issue as far as it relates to England.  

I hope the information above is helpful.   

Yours sincerely  

Medical Director and Director of Education and Standards, GMC

Mrs D Hocking 
Assistant Coroner for Leicester City and South Leicestershire 

16 December 2021 

Dear Mrs Hocking 

Regulation 28: Report to prevent future deaths 

Thank you for sending us your report regarding the circumstances surrounding the death of Jamie 
O’Connor. We would like to pass on our sincere condolences to Jamie’s family. 

Our standards and guidance 

To provide some background context, the GPhC has a statutory purpose to protect patients by setting 
and upholding the standards for registered pharmacies and the standards for pharmacy professionals 
to ensure that registered pharmacies are safe to provide services, and that pharmacy professionals are 
fit to practise. 

We seek assurance that pharmacy professionals and pharmacies continue to meet our standards. One of 
the methods we use to monitor compliance and establish if safe and effective care is being provided is 
by inspecting pharmacies. Since April 2019 we have published inspection reports on our inspection 
website here. 

We act to protect the public and to uphold public confidence in pharmacy if there are concerns about a 
pharmacy professional or pharmacy on our register. One of our key roles is to investigate concerns 
about pharmacists and pharmacy technicians that could suggest they pose a risk to patient safety or 
could affect the public’s confidence in pharmacy. We also investigate concerns about registered 
pharmacies. 

Pharmacy professionals must also take action to safeguard people, particularly those that are 
vulnerable. All pharmacy professionals are personally accountable for meeting the standards. We expect 
pharmacy professionals to meet our standards, comply with their legal duties, as well as considering any 
relevant guidance when making decisions.  In addition, pharmacy owners are responsible for meeting 
our standards for registered pharmacies and everyone in the pharmacy team should be familiar with 
these standards and play a key role in delivering person-centred care. 

25 Canada Square, London E14 5LQ 
T 020 3714 8000 | F 020 3713 8145 
www.pharmacyregulation.org 

 
 The issues in the report 

I wanted to provide some further information about what we expect from registered pharmacies, 
specifically in the context of providing online services, as this is relevant to the issues you have raised. 

We acknowledge your concern that there is no central tracking system or central database to record 
what each person has been prescribed and dispensed and by whom.  Although this specific aspect is 
outside of our remit, we do produce guidance, which is designed to support pharmacy owners and 
pharmacy professionals to meet our standards. 

Our guidance for registered pharmacies providing services at a distance, including on the internet 
highlights the different risks that pharmacy owners should consider as part of their initial risk 
assessment for the pharmacy when deciding whether or not they can safely, and effectively, sell and 
supply medicines at a distance, rather than in the traditional face-to face way. We published this 
updated guidance in April 2019, which includes more stringent safeguards where medicines are supplied 
to patients at a distance. 

To ensure the safe management and supply of medicines, the guidance sets out the key responsibilities 
of the pharmacy owner in relation to the issues you have outlined in your report. 

In particular, we expect pharmacy owners to: 

  Make sure that their website and the websites of companies they work with are arranged so that 
a person cannot choose a prescription only medicine and its quantity before there has been an 
appropriate consultation with a prescriber. It should be made clear that the decisions about 
treatment are for both the prescriber and the person to jointly consider during the consultation. 
However, the final decision will always be the prescriber’s. 

  Make sure that their pharmacy staff can identify requests for medicines that are inappropriate, 
by being able to identify multiple orders to the same address or orders using the same payment 
details – this includes inappropriate combinations of medicines and requests that are too large 
or too frequent. 

  Make sure they consider the design and layout of their website and make sure that it works 

effectively and looks professional. 

We also expect pharmacy owners make sure that an online prescribing service, or a prescriber, that they 
choose to work with is aware that some categories of medicines are not suitable to be supplied online 
unless further safeguards have been put in place to make sure that they are clinically appropriate.  This 
includes medicines liable to abuse, overuse or misuse, or when there is a risk of addiction and ongoing 
monitoring is important.  In this scenario, the following additional safeguards need to be put in place: 

  The person has been asked for the contact details of their regular prescriber, such as their GP, 

and for their consent to contact them about the prescription. 

   The pharmacy owner has assured themselves that the prescriber will proactively share all 

relevant information about the prescription with other health professionals involved in the care 
of the person (for example their GP). 

  The pharmacy owner has assured themselves that the prescriber has contacted the GP in 
advance of issuing a prescription, and that the GP has confirmed to the prescriber that the 
prescription is appropriate for the patient and that appropriate monitoring is in place. 
If there are circumstances where the person does not have a regular prescriber such as a GP, or 
if there is no consent to share information, and the prescriber has decided to still issue a 
prescription, the pharmacy owner should assure themselves that the prescriber has made a clear 
record setting out their justification for prescribing. 

 

You can read more about our approach to regulating online pharmacies here: 
https://www.pharmacyregulation.org/standards/standards-registered-pharmacies/meeting-online-
pharmacies-guidance-faqs 

We have also worked with other healthcare organisations including regulators, royal colleges and 
faculties and have jointly-agreed High level principles for good practice in remote consultations and 
prescribing that set out the good practice of healthcare professionals when prescribing medication 
online. The ten principles, underpinned by existing expected standards and guidance, include that 
healthcare professionals are expected to: 

  Understand how to identify vulnerable patients and take appropriate steps to protect them 
  Carry out clinical assessments and medical record checks to ensure medication is safe and 

appropriate 

We have also published ‘In practice: Guidance for pharmacist prescribers’, which set outs the key areas 
we expect pharmacist prescribers to consider when applying the standards to their prescribing practice. 
The guidance states that prescribing information should be shared with the person’s prescriber, or 
others involved in their care, so the person receives safe and effective care. 

Taking action if our standards are not met 

Our standards set out compulsory requirements which all pharmacies must follow, and our guidance 
describes how we expect them to do this, in different contexts. The guidance is clear that the pharmacy 
owner is responsible for making sure the guidance is followed. Not following our guidance, or not taking 
the appropriate steps to achieve a desired outcome under our standards, could mean that the pharmacy 
fails to meet one or more of our standards and enforcement action may be taken. 

We have taken enforcement action against the owners of online pharmacies who are supplying high 
risk, habit-forming medicines without appropriate steps being taken to check that the medicine being 
prescribed and dispensed is clinically appropriate for the patient. 

Where our inspectors have found insufficient safeguards in place to manage risks to patients, we have 
served Improvement Notices and/or put conditions on a pharmacy’s registration. Typically, where the 
pharmacies are supplying high-risk medicines, the conditions imposed restrict the sale or supply of 
controlled drugs in line with our enforcement policy. As a result of our enforcement action, there have 
been a number of examples where pharmacies have either decided to stop supplying high-risk 
medicines, or, where this was the main focus of their service, have decided to cease trading altogether. 

 We have also referred individual pharmacy professionals involved in both the prescribing and supply of 
medicines to our Fitness to Practise process where their conduct has fallen short of professional 
standards. If a pharmacy professional’s fitness to practise is found to be impaired, our Fitness to Practise 
Committee can impose a range of sanctions, including suspension or removal from the register. 

We hope this is helpful in providing some further background information about what we expect from 
pharmacies in this context. 

Yours sincerely, 

Chief of Staff / Associate Director of Corporate Affairs